Vincigrip hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vincigrip hard capsules

Paracetamol / Pseudoephedrine hydrochloride / Chlorphenamine maleate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Contents of the leaflet

1. What Vincigrip is and what it is used for
2. What you need to know before taking Vincigrip
3. How to take Vincigrip
4. Possible side effects
5. How to store Vincigrip
6. Contents of the pack and other information

1. What Vincigrip is and what it is used for

Vincigrip is a combination of paracetamol, pseudoephedrine, and chlorphenamine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal discharge.

Pseudoephedrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the symptomatic relief of catarrhal and influenza-like conditions, with or without fever, mild to moderate pain, nasal congestion, and nasal discharge in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before taking Vincigrip

Do not take Vincigrip

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have hyperthyroidism.
• If you are being treated with a monoamine oxidase inhibitor (MAOI), such as certain antidepressants or medicines used to treat Parkinson's disease.
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or to increase heart rate).
• If you are being treated with beta-blockers (medicines used to treat high blood pressure or cardiovascular diseases).
• If you have glaucoma (increased pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease, angina pectoris, or cerebral hemorrhage).
• If you have a serious liver disease.
• If you have severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you are in the first trimester of pregnancy.
• Children or adolescents under 12 years of age must not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vincigrip.

• Do not take more than the recommended dose stated in section 3, "How to take Vincigrip hard capsules".
• Avoid taking this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In chronic alcoholics, do not exceed 2 g/day of paracetamol (4 capsules of Vincigrip).
• If you are taking other products containing nasal decongestants, do not take this medicine.
• Treatment must be stopped at least 24 hours before a surgical procedure.
• The simultaneous use of cocaine and pseudoephedrine may increase cardiovascular effects and the risk of adverse reactions.
• Sudden abdominal pain or rectal bleeding may occur with Vincigrip capsules due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Vincigrip capsules and contact your doctor or seek immediate medical attention. See section 4.
• With Vincigrip capsules, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Vincigrip capsules and contact your doctor or seek immediate medical attention. See section 4.
• Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Vincigrip capsules immediately and seek immediate medical help if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4, "Possible side effects").
• There is a potential for abuse of one of the active ingredients in Vincigrip hard capsules, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continued use may lead to tolerance and result in taking more Vincigrip capsules than the recommended dose to achieve the desired effect, increasing the risk of overdose. Do not exceed the maximum recommended dose or duration of treatment (see section 3).

During treatment with Vincigrip, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

The following patients should consult their doctor before taking this medicine:

• Patients with kidney, heart, or lung diseases, or patients with anemia.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Diabetes mellitus (may increase blood glucose levels).
• Cardiovascular diseases.
• Pheochromocytoma.
• Prostatic hypertrophy (may precipitate urinary retention).
• Bladder neck obstruction.
• Urinary retention.
• Chronic obstructive pulmonary disease (COPD) (the anticholinergic effects of chlorpheniramine may cause thickening of bronchial secretions and airway obstruction).
• Pyloroduodenal obstruction or stenosing peptic ulcer (may worsen).
• Epileptic patients.

Children and adolescents

This medicine is contraindicated in children and adolescents under 12 years of age.

Interference with laboratory tests

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

This medicine may interfere with skin tests using allergens. It is recommended to stop taking this medicine at least 3 days before starting such tests and to inform your doctor.

Athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Other medicines and Vincigrip

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are using any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines to treat tuberculosis: isoniazid, rifampicin.

• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).

• Medicines to increase urine elimination: loop diuretics (furosemide) and other potassium-wasting diuretics (diuretics used to treat hypertension or other conditions).

• Medicines to prevent nausea and vomiting: metoclopramide and domperidone.

• Medicines to treat gout: probenecid and sulfinpyrazone.

• Medicines to treat high blood pressure (hypertension) and arrhythmias (heart rhythm disorders): propranolol.

• Medicines to lower blood cholesterol levels: cholestyramine.

• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).

• Ototoxic medicines (which have ear damage as an adverse effect).

• Photosensitizing medicines (which cause light allergy as an adverse effect).

• Urinary acidifiers: ammonium chloride.

• Urinary alkalinizers: sodium bicarbonate, citrates.

• Inhalational anesthetics.

• Antidepressants (tricyclics and monoamine oxidase inhibitors). See section 2.

• Some medicines to lower blood pressure or increase urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine).

• Central nervous system stimulants: amphetamines, xanthines.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

• Cardiac glycosides (used for heart conditions).

• Thyroid hormones (used for thyroid diseases).

• Levodopa (used to treat Parkinson's disease).

• Nitrates (used to treat angina pectoris).

• Monoamine oxidase inhibitors (MAOIs), including furazolidone (antibacterial) and procarbazine (anticancer): their simultaneous use is not recommended, as they may prolong and intensify the anticholinergic and central nervous system depressant effects of antihistamines.

• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant), or other medicines with anticholinergic action: the anticholinergic effects of these medicines or antihistamines such as chlorpheniramine may be enhanced. If gastrointestinal problems occur, patients should be advised to inform their doctor immediately, as paralytic ileus may occur. See section 2, Warnings and precautions.

• Monoamine oxidase inhibitors (MAOIs): the concomitant administration of this medicine should be avoided, even within 15 days after stopping MAOI treatment (antidepressants such as tranylcypromine, moclobemide; for Parkinson's disease, selegiline; anticancer agents such as procarbazine; or anti-infectives such as linezolid), as increased release of catecholamines may prolong and intensify the vasopressor and cardiac stimulant effects of pseudoephedrine, potentially causing severe hypertension, hyperthermia, and headache.

Do not use with other medicines indicated for relief of nasal congestion.

Use of Vincigrip with food, drinks, and alcohol

While taking this medicine, you must not consume alcoholic beverages, as they may enhance the adverse effects of this medicine.

In addition, the use of medicines containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, liquor, etc., per day) may cause liver damage.

Limit consumption of beverages containing caffeine (coffee, tea, chocolate, cola drinks) while taking this medicine.

Do not take with bitter orange juice, as it may cause a hypertensive crisis.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is contraindicated during the first trimester of pregnancy because it may cause intestinal and facial malformations in the newborn. It should also not be taken during the remainder of pregnancy unless your doctor considers it strictly necessary.

Women who are breastfeeding should not take this medicine, as it passes into breast milk and may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

3. How to take Vincigrip

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 12 years and over: 1 capsule (500 mg paracetamol) every 6 or 8 hours (3 or 4 times daily).

Do not exceed 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

How to take:

Vincigrip is taken orally.

Take the capsule with a glass of water or another non-alcoholic drink.

If the medicine is taken at night, it should be taken a few hours before going to bed to reduce the possibility of insomnia in patients who have difficulty sleeping.

Treatment with this medicine should be based on the presence of symptoms. As symptoms subside, the medication should be discontinued.

Use in children and adolescents

This medicine is contraindicated in children and adolescents under 12 years of age.

Use in patients over 65 years of age

These patients should not take this medicine without first consulting their doctor.

They are more likely to experience adverse effects from pseudoephedrine and chlorpheniramine.

If you take more Vincigrip than you should

If you have taken an overdose, you should go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until up to 3 days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or excessive drowsiness), clumsiness, feeling faint, unsteadiness, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood's alkaline reserve). With prolonged use, plasma volume depletion (reduction in blood volume) may occur.

In more severe cases, the following may occur: low blood potassium (hypokalaemia), mental disorder with altered perception of reality (psychosis), seizures, coma, and hypertensive crises.

Treatment of overdose is most effective if started within 4 hours of ingestion.

Patients receiving treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, seek immediate medical attention at your doctor’s office or the nearest hospital emergency department, or contact the Toxicology Information Service (telephone: 91 562 04 20), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of the combination of paracetamol, chlorpheniramine and pseudoephedrine. Their frequency cannot be accurately estimated from the available data.

The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness and muscle weakness, which may disappear after 2–3 days of treatment in some patients. Difficulty in facial movements, clumsiness, tremor, sensory disturbances and tingling; blurred vision or double vision, dryness of nose and throat, thickening of mucus secretions, dry mouth, loss of appetite, taste or smell disturbances, gastrointestinal discomfort (which may decrease if the medicine is taken with food), such as nausea, vomiting, diarrhoea, constipation and stomach pain, urinary retention and increased sweating.

The adverse effects that may occur less frequently are:

Nervous excitement (usually with high doses and more commonly in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, anxiety, headache, lack of coordination, tremors and even seizures.

Other possible adverse effects include: dilated pupils, cardiac disturbances (usually due to overdose), such as rapid heartbeat (tachycardia), irregular heartbeat (palpitations) and disturbances in heart rhythm (arrhythmias). Increased blood pressure (hypertension), mainly in hypertensive patients, or decreased blood pressure (hypotension). Cases of intestinal disorders with blood in the stool have been reported within a few days after starting treatment.

Skin reactions such as hardened skin lesions (erythema), itching and dermatitis.

Difficulty or pain during urination. Blood disorders (changes in blood count such as agranulocytosis, leucopenia, aplastic anaemia or thrombocytopenia), with symptoms such as unusual bleeding, sore throat or fatigue; severe hypersensitivity reactions, anaphylactic reaction (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue and breathing difficulties), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Hearing disturbances, chest tightness, breathing sounds (wheezing), oedema (swelling). Liver disorders, which may present as stomach or abdominal pain and dark urine, sexual impotence and menstrual disturbances.

Adverse effects that may occur rarely:

Malaise, increased blood levels of transaminases, hallucinations (more frequent with high doses), nightmares, screaming and confusion in children, slow heartbeat or bradycardia (frequent with high doses).

Adverse effects that may occur very rarely:

Kidney disorders, cloudy urine, urticaria, jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), myocardial infarction and severe skin reactions.

Adverse effects with unknown frequency (cannot be estimated from the available data):

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are taking paracetamol (see section 2).

Hepatitis that may lead to acute liver failure, angioedema (generalized hives accompanied by swelling of feet, hands, throat, lips and airways), very severe blistering skin reactions (such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Acute Generalized Exanthematous Pustulosis), and inflammation of the colon due to insufficient blood supply (ischaemic colitis). Reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Serious conditions affecting the blood vessels in the brain, known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop taking Vincigrip hard capsules immediately and seek urgent medical attention if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vincigrip

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vincigrip

The active substances are: paracetamol, pseudoephedrine hydrochloride and chlorpheniramine maleate. Each capsule contains 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 4 mg of chlorpheniramine maleate.

The other components (excipients) are: magnesium stearate and the capsule colourings indigo carmine (E-132), erythrosine (E-127) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Vincigrip is presented as red and white hard gelatin capsules.

Each pack contains 12 capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the most recent revision of this leaflet: January 2025

Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es